Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dutasteride

Criteria

Inclusion Criteria:

• completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only)

• compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline

Exclusion Criteria:

• N/A